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About Clinical Trials

Before any drug is approved for general use, it must go through three phases of testing called "clinical trials". People volunteer to participate in these trials and must meet strict criteria before being accepted into a study. On average, it costs an estimated $800 million and takes 10-15 years for an experimental drug to move from the laboratory to a patient.

Testing Phases

There are three primary stages that a new drug must go through before being approved by the U.S. Food and Drug Administration (FDA). After approval, a phase 4 study examines possible long-term effects.

  • Phase I clinical trials test new treatments in small groups of people (20-100) to evaluate safety, determine dosage and identify side effects.
  • Phase II trials test the drug on 100-500 people to further evaluate its safety and effectiveness.
  • Phase III studies test the drug on 1000-5000 people to confirm its effectiveness, monitor side effects and compare it to commonly used treatments.
  • Phase IV studies are done after the drug or treatment has been marketed to collect information about its effect in various populations and any side effects associated with long-term use.

Benefits of a Clinical Trial

Enrolling in clinical trial programs can be very beneficial. Expensive blood work, treatment medications, and clinical monitoring are usually provided free of charge for those accepted into a study. Clinical trials also provide the opportunity to potentially benefit from the latest advances in medical science.

Your Doctor's Role in Clinical Trials

Talk to your doctor about clinical trials that may benefit you. Ask your doctor to help you sift through the pros and cons of enrolling in a clinical trial and the different treatment options.

Be clear about whether the drug being tested is better or riskier for you than no treatment.  Is it better than existing treatments that are already approved?

Although you can leave a clinical trial at anytime, be sure to let the doctor or nurse know why you want to leave. You are also encouraged to see your primary health care provider on a regular basis even if you are in a clinical trial.

10 Questions to Ask Your Doctor Before Enrolling in a Clinical Trial

  • Where is the site located and how often will I need to go there?
  • Will I be charged for any part of the trial or will my insurance pay for it?
  • Why do researchers think the treatment will work better than standard (FDA-approved) treatment?
  • Who is most likely to benefit from this drug and what criteria have been associated with success?
  • How many people have tested the drug and what has happened to them?
  • What are the possible short and long-term side effects?
  • What tests or procedures are involved and how are patients safely monitored while on the treatment?
  • What happens to my hepatitis B when I stop taking the drug?
  • What is the follow-up care after the clinical trial ends?
  • If this drug doesn't work for me, am I eligible to try another one?
Page last modified October 21, 2009

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